Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System

Neurological Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, Cirq Robotic Alignment Cranial And Spine System.

Pre-market Notification Details

Device IDK210989
510k NumberK210989
Device Name:Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-02
Decision Date2021-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481141622 K210989 000
04056481141608 K210989 000
04056481141592 K210989 000
04056481141585 K210989 000
04056481141578 K210989 000
04056481141561 K210989 000

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